Myopie-STOP: Topical 0.01% Atropine for the Control of Fast Progressing Myopia

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04173780
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 64.6
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular.

The management of myopia and its complications is therefore a major public health issue.

All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia.

The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).

Condition or Disease	Intervention/Treatment	Phase
Myopia Progressing; Childhood	Drug: Atropine 0.01%; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Topical 0.01% Atropine for the Control of Fast Progressing Myopia
• Actual Study Start Date: Feb 12, 2020
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atropine 0.01%	Drug: Atropine 0.01%; 1 drop per day in both eyes for 1 year
Placebo Comparator: Placebo	Drug: Placebo; 1 drop per day in both eyes for 1 year

Outcome Measures

Primary Outcome Measures

1. Myopia in spherical diopters [12 months]

   Automatic measurement of myopia in spherical diopters under cycloplegia

2. Myopia in spherical diopters [9 months]

   Automatic measurement of myopia in spherical diopters under cycloplegia

3. Myopia in spherical diopters [6 months]

   Automatic measurement of myopia in spherical diopters under cycloplegia

4. Myopia in spherical diopters [3 months]

   Automatic measurement of myopia in spherical diopters under cycloplegia

Secondary Outcome Measures

1. Axial length [12 months]

2. Axial length [6 months]

3. Axial length [3 months]

4. Axial length [9 months]

5. Adverse events [12 months]

6. Adverse events [9 months]

7. Adverse events [6 months]

8. Adverse events [3 months]

9. Quality of life questionnaire [12 months]

10. Quality of life questionnaire [9 months]

11. Quality of life questionnaire [6 months]

12. Quality of life questionnaire [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Children from 4 to 12 years

• Myopia from -1 to -6

• Fast progressing myopia (>0.75 diopter / year)

• Informed consent obtained

Exclusion Criteria:

Astigmatism > 1.5 diopters

• Anisometropia > 2 diopters

• Concomitant pathology of anterior or posterior segments

• Other ocular diseases (Ocular inflammation, strabismus …)

• Atropine hypersensitivity or allergy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Strasbourg	Strasbourg		France	67000

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

• Principal Investigator: Arnaud SAUER, MD, University Hospital, Strasbourg, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT04173780
• Other Study ID Numbers: 7343
• First Posted: Nov 22, 2019
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Strasbourg, France: Myopia (Progressing); Childhood; Atropine 0,01%
• Additional relevant MeSH terms: Myopia; Atropine

Study Results

No Results Posted as of Jul 8, 2022